| CTRI Number |
CTRI/2026/03/106199 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Balance and Proprioception Exercises Compared with Strengthening Exercises for Preventing Recurrent Ankle Sprains in Young Adults |
|
Scientific Title of Study
|
Comparative Effectiveness of Proprioceptive and Balance Training versus Conventional Strengthening in Improving Stability and Reducing Recurrence of Ankle Sprains in Young Adults. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vishesh Kumar |
| Designation |
Post Graduate student |
| Affiliation |
Prakash Institute of Physiotherapy, Rehabilitation and Allied Medical Sciences |
| Address |
Prakash Institute of Physiotherapy Rehabilitation and Allied Medical Sciences Gautam budh nagar Uttar Pradesh 201303
Gautam Buddha Nagar UTTAR PRADESH 201303 India |
| Phone |
8766258369 |
| Fax |
|
| Email |
visheshkumar1700@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
PUJA SHARMA |
| Designation |
Associate Professor |
| Affiliation |
Prakash Institute of Physiotherapy, Rehabilitation and Allied Medical Sciences |
| Address |
Prakash Institute of Physiotherapy Rehabilitation and Allied Medical Sciences Gautam budh nagar Uttar Pradesh 201303
Gautam Buddha Nagar UTTAR PRADESH 201303 India |
| Phone |
9873252361 |
| Fax |
|
| Email |
s.puja47@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
dr Puja Sharma |
| Designation |
Associate Professor |
| Affiliation |
Prakash Institute of Physiotherapy, Rehabilitation and Allied Medical Sciences |
| Address |
Prakash Institute of Physiotherapy Rehabilitation and Allied Medical Sciences Gautam budh nagar Uttar Pradesh 201303
Gautam Buddha Nagar UTTAR PRADESH 201303 India |
| Phone |
9873252361 |
| Fax |
|
| Email |
s.puja47@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
VISHESH KUMAR |
| Address |
Prakash Institute of Physiotherapy Rehabilitation and Allied Medical Sciences Gautam budh nagar Uttar Pradesh 201303 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vishesh Kumar |
Flexlife Physiotherapy and Rehabilitation Center |
E 303 Block E Delta I Greater Noida Gautam Buddha Nagar UTTAR PRADESH |
8766258369
Visheshkumar1700@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIPRAMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M799||Soft tissue disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional physiotherapy |
Participants in Group B will receive conventional physiotherapy consisting of cryotherapy if required, ankle range of motion exercises, stretching exercises and theraband strengthening exercises for dorsiflexion, plantarflexion, inversion and eversion.
The treatment duration and frequency will be the same as the intervention group with three sessions per week for twelve weeks. |
| Intervention |
Proprioceptive and Balance Training with Conventional Physiotherapy |
Participants in Group A will receive conventional physiotherapy along with proprioceptive and balance training exercises. Conventional physiotherapy will include cryotherapy if required, active ankle range of motion exercises, gastrocnemius and soleus stretching and theraband strengthening exercises for dorsiflexion, plantarflexion, inversion and eversion.
In addition, participants will undergo progressive proprioceptive and balance training including single leg stance exercises, foam surface balance training, perturbation training, hop stabilization drills and agility ladder exercises.
The intervention will be conducted three sessions per week for a duration of twelve weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Young adults aged 18 to 25 years with a history of at least one lateral ankle sprain within the past twelve months and diagnosed with chronic ankle instability defined by a Cumberland Ankle Instability Tool score of less than or equal to twenty four. Participants must be able to bear weight independently and willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
Participants with acute ankle sprain within the past six weeks.Individuals with grade three ankle sprain requiring immobilization.
History of ankle fracture or ankle surgery.
Neurological disorders affecting balance.
Systemic inflammatory joint diseases. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Y Balance Test
Star Excursion Balance Test |
Baseline
6 weeks
10 weeks
3 months follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Self reported ankle instability measured using Cumberland Ankle Instability Tool
Functional outcome measured using Foot and Ankle Ability Measure
Recurrence of ankle sprain during follow up |
Baseline
6 Weeks
12 Weeks
3 Month Follow Up |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="11" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Recurrent ankle sprains are one of the most common musculoskeletal injuries among young adults and may lead to chronic ankle instability characterized by repeated episodes of instability, pain and functional limitation. Conventional physiotherapy programs commonly focus on strengthening and stretching exercises but may not fully address deficits in proprioception and neuromuscular control. Proprioceptive and balance training aims to improve joint position sense, neuromuscular coordination and dynamic stability of the ankle joint. This randomized controlled trial aims to compare the effectiveness of proprioceptive and balance training combined with conventional physiotherapy versus conventional physiotherapy alone in improving balance, functional outcomes and preventing recurrence of ankle sprains in young adults. A total of sixty participants aged between eighteen and twenty five years with chronic ankle instability will be recruited and randomly allocated into two groups. Outcome measures including Y Balance Test, Star Excursion Balance Test, Cumberland Ankle Instability Tool and Foot and Ankle Ability Measure will be assessed at baseline, six weeks and twelve weeks. Participants will also be followed for three months to monitor recurrence of ankle sprains. The study will help determine whether proprioceptive and balance training provides superior improvement in ankle stability and functional outcomes compared with conventional strengthening programs. |